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Phase 2a Multi-Center Prospective, Randomized Trial to Evaluate the Safety & Efficacy of Topical PEP-TISSEEL for Diabetic Foot Ulcers (DFU)

NCT06319287 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 59

Last updated 2026-01-20

No results posted yet for this study

Summary

This is a Phase 2a Multi-Center, Prospective, Randomized, Controlled Study aimed to evaluate the Safety and Efficacy of Topically Applied PEP-TISSEEL in Subjects with Diabetic Foot Ulcers (DFU)

Conditions

  • Diabetic Foot Ulcer

Interventions

BIOLOGICAL

PEP (Purified Exosome Product) / TISSEEL

PEP Drug Product is a lyophilized powder contained within a 10R glass vial. PEP Drug Product is a lyophilized powder derived from apheresed platelets in plasma. The powder cake weighs approximately 75 mg per vial. This protocol will evaluate 2 vials of PEP Drug Product delivered in 10 mL TISSEEL fibrin sealant (15mg/mL PEP-TISSEEL) for 12 weeks. TISSEEL is a fibrin sealant indicated as an adjunct to standard surgical techniques (such as suture and ligature) to prevent leakage from colonic anastomoses following the reversal of temporary colostomies

Sponsors & Collaborators

  • Professional Education and Research Institute

    collaborator OTHER

  • Rion Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-02-27
Primary Completion
2025-04-23
Completion
2025-11-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06319287 on ClinicalTrials.gov